Abbott Sensor Based Glucose Monitoring System Paediatric Study
- Conditions
- Diabetes Mellitus
- Interventions
- Device: FreeStyle Libre Flash Glucose Monitoring System
- Registration Number
- NCT02388815
- Lead Sponsor
- Abbott Diabetes Care
- Brief Summary
To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- Age ≥ 4 years, ≤17 years
- Each participant has an identified Caregiver of ≥18 years
- Type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII)
- Currently testing blood glucose, on average at least 2 times per day
- In the investigator's opinion, technically capable of using device (participant and/or caregiver).
- Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
- Currently prescribed oral steroid therapy for any acute or chronic condition
- Currently receiving dialysis treatment or planning to receive dialysis during the study
- Female participant known to be pregnant
- Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
- Currently using a continuous glucose monitoring (CGM) device
- Known (or suspected) allergy to medical grade adhesives
- In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System
- Primary Outcome Measures
Name Time Method Point Accuracy 14 days Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.
The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.
Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University Hospitals Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Harrogate & District NHS Foundation Trust
🇬🇧Harrogate, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Oxford Radcliffe Hospital NHS Trust
🇬🇧Oxford, United Kingdom
Southampton University Hospital NHS Trust
🇬🇧Southampton, United Kingdom